FDA product code GRO: Antisera, Fluorescent, All Types, Hemophilus Spp.
GRO is the FDA product code for antisera, fluorescent, all types, hemophilus spp.. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under GRO, from 4 different applicants. The average 510(k) review took 52 days (median 40). FDA has posted 1 recall for GRO devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Types, Hemophilus Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3300 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRO clearance
Top GRO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 1 | 1985-07-08 |
| Remel Co. | 1 | 1984-01-03 |
| Pharmacia, Inc. | 1 | 1980-11-12 |
| Armkel, LLC | 1 | 1980-04-04 |
Most recent GRO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851271 | Gen-Probe, Inc. | LEGIONELLA CULTURE CONFIRMATIN KIT | 1985-07-08 | 98 |
| K834067 | Remel Co. | LEGIONELLA DIFFERENTIATION DISK | 1984-01-03 | 39 |
| K802423 | Pharmacia, Inc. | PHADEBACT HAEMOPHILUS TEST | 1980-11-12 | 40 |
| K800493 | Armkel, LLC | BACTOGEN-H. INFLUENZAE TYPE B | 1980-04-04 | 31 |
Recalls for GRO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-10-22.
Frequently asked questions
What is FDA product code GRO?
GRO is the FDA product code for antisera, fluorescent, all types, hemophilus spp.. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel.
What device class is GRO?
Class II, regulation 21 CFR 866.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRO?
Across 4 cleared submissions the average was 52 days from receipt to decision (median 40).
Which companies have the most GRO clearances?
Gen-Probe, Inc. (1); Remel Co. (1); Pharmacia, Inc. (1); Armkel, LLC (1).
Have GRO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-10-22.
Next steps
- Run an FDA pathway report with predicate devices for product code GRO
- Run a recall and safety report across every GRO manufacturer
- Watch product code GRO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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